May 17
“AI seems to be a thing. Everybody’s excited about ChatGPT.” Asking ChatGPT to list current medical device trends as preparation for our monthly content meeting has turned into our latest group blog.Not surprisingly, the StarFish team identified the same trends proposed by ChatGPT- and more – with six of the most interesting trends making it into this blog.
May 1
Tolerancing Simulation for Medical Device Optical Systems
Tolerancing is often an essential step in understanding the manufacturing/assembly requirements of an optical system designed for use in medical devices. The use of optical design software for tolerancing simulations is a valuable tool for identifying the specific manufacturing/alignment errors that can be allowed and their limits.
Zemax OpticStudio® is a popular optical design software that can facilitate the design of optical medical devices. The software includes a versatile tool for simulating the effects of tolerance errors on the performance of an optical system. In this blog, we give a basic overview of tolerancing in Zemax OpticStudio’s sequential mode.
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May 1
Building a Customized Microscope for a Microfluidics Application
Several companies offer microscopes specifically designed for microfluidic applications and cell imaging.
However, they are often price prohibitive and, in most cases, do not readily fit the specific requirements for a particular microfluidic application.
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May 1
Revolutionizing Medical Imaging Devices with Optical Imaging
Optical imaging tools can enhance the crucial role of biomedical imaging in accurately identifying diseases and monitoring their progression.
Conventional medical imaging devices such as X-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, and positron emission tomography (PET) are commonly used in clinical settings (Figure 1). However, these imaging modalities are limited in their resolution, only being able to capture images at the millimeter scale or greater.
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May 1
FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions
The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions.
The PCCP is a critical component of the regulatory approval process, as it ensures that changes to the AI/ML algorithms or models, that drive the device software functions are properly validated and verified before being implemented. Continue reading »
May 1
Incoherent-Light Hazard Classification for Medical Devices
There are numerous light-hazard classification standards that may pertain to your medical device: ISO 60601-2-57, IEC 62471, ANSI RP-27-20, ISO 15004-2, ANSI Z80.36, ISO 10936-2, ISO 10939, and so on…
In this blog post, I’ll examine certain commonalities and points of potential confusion of the “big 4” incoherent-light-source safety standards: IEC 62471 and ANSI RP-27-20 for “general biophotonic hazards”, and ISO 15004-2 and ANSI Z80.36 for hazards specific to ophthalmic devices and the patients to which they are applied.
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Apr 13
18 Tips to Optimize Your Return to Office
We began returning to office in late 2022 and continue developing new work practices, adjusting to new renovations, and bonding with colleagues added during our months of remote working.
This blog offers tips and insights from StarFish Medical employees from their experiences transitioning to working in the office or hybrid working. Continue reading »
Apr 1
Top Lessons in Project Management of Medical Device Development
I realized recently that I’ve been leading product development projects for more than a quarter century now, with a bunch more years of product design experience on top of that.
Over this time, I’ve collected a list of project management tips that seem more and more valid to me as time goes by. Continue reading »
Apr 1
Important Considerations when Designing Labels for Medical Devices
The FDA requires a UDI in both plain text and machine-readable format (i.e., bar code) to be printed on a label that is attached to the device and the device packaging for traceability through distribution and service life of the device.
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Apr 1
Revolutionizing Wound Care: Smart Bandages with Wearable Sensors
Chronic non-healing wounds cause a significant burden on the healthcare system and are the leading cause of limb amputation.
Integrating smart bandages within the healthcare system can reduce hospitalization rates and in-clinic wound treatment time, hence reducing the overall burden on the healthcare system.
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Apr 1
Computational Modeling and Simulation (CMS) is Changing Medical Device Development
The 21st century is going to bring massive changes to the medical device development sector and the role of computational modeling and simulation-based medical device development is expected to increase further.
In silico studies (physics based computational modeling and simulation) are already being used to virtually test medical devices.
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Mar 7
International Women’s Day – Facilitating Career Growth & Mentorship
As a medical engineering firm operating within a male dominated industry, StarFish Medical has not only been mindful of how we maintain a gender-diverse management team, but deliberate in how we attract female employees and create an environment that supports their long-term career growth.
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